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Mobile Medical X-ray High Frequency High Voltage Generator

PSG-M50LD, PSG-M40LD, PSG-M32LD, PSG-M50HD, PSG-M40HD, PSG-M32HD

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Suzhou Powersite Electric Co., Ltd.
Manufacturer SRN: CN-MF-000018914
UDI-DI: 06973858210201
Basic UDI-DI: 6973858212b0102010038G
Reference: PSG-M32LD
EMDN: Z11039011
EMDN description: HIGH VOLTAGE X-RAY GENERATORS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Medical X-ray High Frequency High Voltage Generator

PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR80

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Suzhou Powersite Electric Co., Ltd.
Manufacturer SRN: CN-MF-000018914
UDI-DI: 06973858210171
Basic UDI-DI: 6973858212b0102010018C
Reference: PSG-HR50
EMDN: Z11039011
EMDN description: HIGH VOLTAGE X-RAY GENERATORS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable High-Pressure Angiographic Syringes

HK-001 PP

Class IIaMDR 2017/745On the marketAdministering medicineDirect markingSingle useSterile

Manufacturer: JIANGXI HAWK MEDICAL SUPPLIES Co.,LTD
Manufacturer SRN: CN-MF-000037292
UDI-DI: 06973648247172
Basic UDI-DI: 697364824717-748XH
Reference: 717-956
EMDN: Z11039013
EMDN description: ANGIOGRAPHIC INJECTORS
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Intraoral Camera

HDI-712D, HDI-712C, HDI-712B, HDI-220D, HDI-220C, HDI-220B, HDI-210, HDI-200A, HDI-100A

Class IMDR 2017/745On the marketActive device

Manufacturer: Shanghai Handy Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000030072
UDI-DI: 06973130880160
Basic UDI-DI: 697313088HDIQ3
Reference: HDI-712B
EMDN: Z11039010
EMDN description: PHOTO CAMERAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

06971576833610

uMC Reveal E

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Healthcare Co.,Ltd.
Manufacturer SRN: CN-MF-000008501
UDI-DI: 06971576833610
Basic UDI-DI: 697157683361NP
Reference: 88001399
EMDN: Z11039009
EMDN description: FLUOROSCOPY DEVICES
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

06971576833603

uMC Reveal X

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Healthcare Co.,Ltd.
Manufacturer SRN: CN-MF-000008501
UDI-DI: 06971576833603
Basic UDI-DI: 697157683360NM
Reference: 88001398
EMDN: Z11039009
EMDN description: FLUOROSCOPY DEVICES
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

06971576833092

uMC 560i

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Healthcare Co.,Ltd.
Manufacturer SRN: CN-MF-000008501
UDI-DI: 06971576833092
Basic UDI-DI: 697157683309NM
Reference: 88000010
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

CT Contrast Injection Device

Ascend A；Ascend A1；Ascend A2；Ascend A3

Class IIbMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Nanjing Jusha Display Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027215
UDI-DI: 69715532050418
Basic UDI-DI: 697155320injectorA9
Reference: 0306
EMDN: Z11039014
EMDN description: MULTIPLE CONTRAST AGENT INJECTORS
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:01

Manufacturer products Authorised representative products Authorised representative actors View details

06971219910449

ES-1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Guilin Yikeshi Medical Instrument Co., Ltd
Manufacturer SRN: CN-MF-000019045
UDI-DI: 06971219910449
Basic UDI-DI: 697121991ES01HF
Reference: ES-1
EMDN: Z11039010
EMDN description: PHOTO CAMERAS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Mobile Digital Radiography X-ray System

M50-1A, M800-1E, M880, M40-1, M40-1A

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014174
UDI-DI: 06938964315011
Basic UDI-DI: 693896431500NN
Reference: N/A
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:22

Manufacturer products Authorised representative products Authorised representative actors View details

06938396402327

SR-8230, SR-8230S, SR-8210, SR-8210S, SR-8100, SR-8100S, SR-8000, SR-8000S, SR-9100, SR-9200, SR-9300

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000010834
UDI-DI: 06938396402327
Basic UDI-DI: 693839640030023X4300000GB
Reference: SR-9100
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:20

Manufacturer products Authorised representative products Authorised representative actors View details

HIGH VOLTAGE X-RAY GENERATORS

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle use

Manufacturer: Liaoning DTKL Technology Co., Ltd
Manufacturer SRN: CN-MF-000033792
UDI-DI: 06976512680822
Basic UDI-DI: 6976512685065DT
Reference: DTXR-65HF
EMDN: Z11039011
EMDN description: HIGH VOLTAGE X-RAY GENERATORS
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

04719879963205

32” 4K 3D LCD Display

Class IMDR 2017/745On the marketActive device

Manufacturer: MedicalTek Co., Ltd.
Manufacturer SRN: TW-MF-000014722
UDI-DI: 04719879963205
Basic UDI-DI: 471987996DisplayES
Reference: GN32UGN01.0
EMDN: Z11039004
EMDN description: TELEVISION SYSTEMS
First on market country: Germany
Authorised representative: KOMAS Medical Technology GmbH
Last updated: 02.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Gel Pad S

Class IMDR 2017/745On the marketSingle use

Manufacturer: Nemoto Kyorindo Co., Ltd.
Manufacturer SRN: JP-MF-000004827
UDI-DI: 14560138482701
Basic UDI-DI: 456013848270AS
Reference: L-05E
EMDN: Z11039085
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Medicor International NV/SA
Last updated: 01.07.2026 23:56

Manufacturer products Authorised representative products Authorised representative actors View details

XD2000 ST-M

Class IMDR 2017/745On the market

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410438888
Basic UDI-DI: 454741010100000000001243K
Reference: 04547410438888
EMDN: Z11039080
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 01.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

42624007200490

Delft One

Class IIbMDR 2017/745Not intended for EU market

Manufacturer: Delft Imaging Systems B.V.
Manufacturer SRN: NL-PR-000033500
UDI-DI: 42624007200490
Basic UDI-DI: 426240072DelftOneVU
Reference: DelftOne
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 23:34

Manufacturer products View details

Portable PACS with CAD4TB

Class IIbMDR 2017/745Not intended for EU market

Manufacturer: Delft Imaging Systems B.V.
Manufacturer SRN: NL-PR-000033500
UDI-DI: 42624007200322
Basic UDI-DI: 426240072PACSCAD4TBEK
Reference: Portable PACS with CAD4TB
EMDN: Z11039082
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 23:34

Manufacturer products View details

42624007200254

CAD4TBBox

Class IIbMDR 2017/745On the market

Manufacturer: Delft Imaging Systems B.V.
Manufacturer SRN: NL-PR-000033500
UDI-DI: 42624007200254
Basic UDI-DI: 426240072CAD4TBRC
Reference: CAD4TBBox
EMDN: Z11039082
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 23:34

Manufacturer products View details

12M

MRCAM

Class IMDR 2017/745On the marketActive device

Manufacturer: MRC Systems GmbH Medizintechnische Systeme
Manufacturer SRN: DE-MF-000011848
UDI-DI: 04262355231201
Basic UDI-DI: 426235523MRCAM7X
Reference: 12M
EMDN: Z11039010
EMDN description: PHOTO CAMERAS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:26

Manufacturer products View details

Signal MR Head

Class IMDR 2017/745On the marketActive device

Manufacturer: Floy GmbH
Manufacturer SRN: DE-MF-000016503
UDI-DI: 04260761040400
Basic UDI-DI: 426076104MRHEAD8Q
Reference: Signal MR Head
EMDN: Z11039092
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:25

Manufacturer products View details